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Quality Assurance Manager

Department: Quality & Operational Excellence

Location: Milpitas, California, United States

Company

An idea conceived in a University of Cambridge laboratory in 1998, Abcam plc (www.abcamplc.com) began life as an innovative and entrepreneurial start-up, spearheaded by like-minded individuals who shared a common purpose of providing the scientific community with quality antibody reagents, as well as trustworthy and up-to-date information about their uses and limitations. Abcam has now grown to become a leading supplier of protein research tools to life scientists, whilst always maintaining the core collaborative values assumed at its inception.

 

Abcam now supports life science researchers in their quest to understand the cause of disease and ultimately offer improvements to diagnoses and treatments. To achieve this outcome, the company both develops and manufactures its own products in specialist facilities across the globe, and sources from over 400 partners, offering scientists the newest, most innovative and highest quality research tools available globally, regardless of source. With a customer base of research scientists who require high performance products with detailed technical specifications, 64% of global researchers use Abcam products.

 

There are six broad categories of products: primary antibodies; secondary antibodies; functional assays; ELISA and other kits; biochemicals, proteins and peptides; and more recently, gene-edited cell lines and lysates. Abcam’s information-rich products, together with expert customer support and fast delivery makes it the researcher’s choice.

 

Mission – To serve life scientists to achieve their mission faster

Vision To be the most influential life sciences company for researchers worldwide

Strategy To deliver sustainable, profitable, long-term growth

 
 

The Role

Following the acquisition of gene editing platform and oncology product portfolio of Applied StemCell Inc, we are now looking to expand the team as we look to become a leader in the cell engineering field. With this in mind, we are recruiting for a Quality Assurance Manager to join the team, reporting to the Global Director of Quality Assurance.  

You’ll work collaboratively with our global Quality Assurance team to ensure our quality systems in our Milpitas site adhere to the ISO 13485:2016 standard. In doing so, you’ll help our customers achieve their research missions, faster.

Key Responsibilities

  • Responsible for managing the daily quality assurance activities to ensure the design, control and manufacturing of our products are in compliance with FDA Quality System 21 CRF, Part 820) and ISO13485 Regulations.

  • Manage the maintenance and integration activities related to the Quality Systems, providing assistance with internal team members, customer and regulatory audits, and identifying opportunities for and implementation of continuous improvement. Responsible for continuous improvement of core quality systems to ensure optimization without compromising regulatory compliance.

  • Provide hands-on ownership for the various elements of the quality system to ensure successful performance during third-party audits and regulatory inspections.

  • Lead and manage Quality investigations.
  • Provide support to internal functions in the application, maintenance and improvement of quality systems and department specific procedures.

  • Lead root cause analysis and develop associated CAPA to prevent recurrence and ensure completion of effectiveness checks.

  • Lead the program for developing and justifying meaningful quality system metrics and provide regular updates to Quality management.

  • Initiate updates and creation of new functional SOPs as required.

  • Serves as Quality representative for Quality System audits and regulatory inspections as needed.

  • Manage some operation related projects (e.g. customer service and  external collaborations) .

  • Manage direct report(s) for quality assurance and other operational functions (e.g., customer service).

  • Comply with all safety and quality standards.
  • Manage regulatory related affairs as needed in territories that the products are sold.

  • Manage regulatory compliance issues and communication with regulatory bodies in US and outside of US.

 

Skills and Experience Required

  • Bachelor’s Degree in biochemistry, pathology, cell and molecular biology, immunology or other Life Sciences required; Master’s Degree preferred.

  • Minimum 3 years of industrial working experience under ISO 13485 or FDA QSR is required. Experience in establishing and implementing above mentioned quality system is a plus.

  • Experience in administering quality management systems such as US FDA QSR (21 CFR: 820) and ISO 13485:2016 is preferred

  • Familiarity with IVD immuno-assay product development process such as design control and IVD product manufacturing.

  • Understanding of immunohistochemistry (IHC) products for anatomic pathology application is a plus.

  • Excellent working knowledge and understanding of GMP-related requirements and proficiency of regulatory guidelines with the ability to assess risk.

  • Working knowledge of developing and establishing quality indicators and metrics.

  • Detail oriented with quality assurance background with solid problem-solving acumen.

  • Ability to work effectively in a team environment with great organization skills.

  • Excellent working knowledge of Quality Systems and cGMP standards applicable to assay product development process.

  • Ability to analyze and reconcile moderate to complex issues independently.

  • Must be an individual with proven initiative and demonstrated accountability in a fast-paced environment.

  • Excellent verbal and written communication and interpersonal skills.

  • Proficient with Microsoft Office

Location

The team are currently co-located in the current Applied StemCell Inc facility Milpitas, CA, although are planned to relocate to a nearby facility by Summer 2020.

Pay and Benefits

In addition to competitive salaries, we offer an attractive and flexible benefits package (including our award-winning share scheme), a culture focused on well-being and opportunities for growth and development, and a highly flexible working environment.